NCT00960661已完成3 期
A Randomized Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes Who Were Previously Treated by Basal Insulin Glargine With Either Metformin or Metformin and Sulfonylurea
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,036
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30
研究概览
简要总结
The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been taking a basal insulin Glargine, at dose of ≥ 20 units/day, for at least 3 months prior to study start.
- •Have been taking basal insulin Glargine at dose of ≥ 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start:
- •Metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start; or
- •Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start.
- •Have an HbA1C > 7.0% and ≤ 10.0%.
- •Have a body mass index (BMI) between ≥ 25 and ≤ 45 kg/m2.
排除标准
- •Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label.
- •Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications).
- •Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week.
- •Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start.
- •Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Have previously completed or been withdrawn from this study after enrollment.
研究组 & 干预措施
Exenatide (BET)
Experimental
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
干预措施: exenatide (Drug)
Exenatide (BET)
Experimental
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
干预措施: Metformin (Drug)
Exenatide (BET)
Experimental
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
干预措施: Insulin/ Glargine (Drug)
Insulin Lispro (BBT)
Active Comparator
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
干预措施: insulin lispro (Drug)
Insulin Lispro (BBT)
Active Comparator
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
干预措施: Metformin (Drug)
Insulin Lispro (BBT)
Active Comparator
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
干预措施: Insulin/ Glargine (Drug)
结局指标
主要结局
Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30
时间窗: Baseline, 30 weeks
Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline).
次要结局
- Percentage of Participants Achieving HbA1C < 7.0%(Week 30)
- Percent of Participants Achieving HbA1c ≤ 6.5%.(Week 30)
- Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.(Baseline, Week 30)
- Change in Total Cholesterol From Baseline to Week 30(Baseline, week 30)
- Change in High Density Lipoprotein (HDL) From Baseline to Week 30(Baseline, week 30)
- Change in Low Density Lipoprotein (LDL) From Baseline to Week 30(Baseline, Week 30)
- Change in Body Weight From Baseline to Week 30.(baseline, week 30)
- Change in Systolic Blood Pressure (SBP) From Baseline to Week 30(Baseline, Week 30)
- Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30(baseline, Week 30)
- Daily Insulin Glargine Dose at Baseline and at Week 30(Baseline, week 30)
- Major Hypoglycemia Rate Per Year(30 weeks)
- Minor Hypoglycemia Rate Per Year(30 weeks)
研究者
研究点 (1)
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